Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004577174

FEI Number

3004577174

Entity Name

ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.

City/State/Country

Tampa, FL, US

Establishment Address

13812 Wright Cir, Tampa, FL 33626, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARJ MEDICAL, LLC (Owner Number: 9078060)

Owner / Operator Contact Address

13812 Wright Circle, --, Tampa, FL 33626, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052708

PMA Number

N/A

All Registered Proprietary Names

PyloPlus 13C Urea Breath Test PyloPlus UBT System PyloPlus Urea Breath Test PYLO PLUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZA	Test, Urea Adult And Pediatric (Breath),	Microbiology	Class 3	866.3110	2020-03-03
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2007-02-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARJ MEDICAL, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004577174. Last updated year: 2026. Please use registration number 3004577174 when referencing this establishment in official correspondence.